HAMILTON T1 Ventilator software defect may cause unexpected shutdown
Hamilton Medical is recalling 2,319 HAMILTON T1 Ventilators due to a software anomaly that may cause the device to stop and enter ambient mode after approximately 91 days of use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification for a critical medical device. A software defect causing ventilator shutdown after approximately 91 days of use poses serious risk to ventilator-dependent patients.
Plain-English summary
Hamilton Medical, Inc. is recalling 2,319 HAMILTON T1 Ventilators, which provide positive pressure ventilatory support to adults, children, infants, and neonates.
The recall is due to a software anomaly. After approximately 91 days of cumulative use, affected ventilators may stop and enter ambient mode without warning. This unexpected shutdown could interrupt critical respiratory support to dependent patients.
The affected ventilators have been distributed throughout the United States, Puerto Rico, Bahamas, Japan, and Mexico. Specific serial numbers have been identified as part of this recall.
Patients and healthcare providers should verify their ventilator serial numbers against the manufacturer's list and contact Hamilton Medical, Inc. for further guidance.
The recalled product
- Product
- HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
- Manufacturer
- Hamilton Medical, Inc.
- Affected units
- 2,319
Distribution
Part of a larger recall action
This product is one of 4 recalled by Hamilton Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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Similar recalls
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FDA (Devices) · 2013-02-06
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